Anesthesia
Conditions
Keywords
propofol, dose-response, elderly, young adults
Brief summary
Propofol's dose-response curve is know for the average adult but propofol's plasmatic concentration under total intravenous anesthesia differences between young and elderly must be modeled. Adaptative clinical trial (Dixon's Up and Down) for determination of ED95% of propofol concentration for hypnosis under general anesthesia for young and elderly adults.
Detailed description
Propofol's dose-response curve is know for the average adult but propofol's plasmatic concentration under total intravenous anesthesia differences between young and elderly must be modeled. Method: adaptative clinical trial (Dixon's Up and Down method) for determination of ED95% of propofol concentration (plasmatic, Marsh model) for hypnosis (BIS ranging from 40 to 60) under general anesthesia for young and elderly adults.
Interventions
DRUGPropofol
Propofol plasmatic concentration (Marsh)
Sponsors
Brasilia University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Both sex * Between 18-28 or 65-75 years old * ASA physical status I or II * no pre-anesthetic medications prescribed * scheduled for surgery under general anesthesia * willing to participate and sign informed consent.
Exclusion criteria
* Contraindications for propofol usage * history of neurologic or psychiatric diseases * drug abusers * users of drugs that alter central nervous system * pregnancy * emergency surgeries * rapid sequence intubation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BIS value greater than 60 or lower than 40 during general anesthesia | BIS value greater than 60 or lower than 40 during general anesthesia | BIS value greater than 60 or lower than 40 during general anesthesia |
Outcome results
None listed